Hypertrophic CardiomyopathyNCT06181617
A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
An observational study of Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases. Phase I is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Quality of life assessment
- How many people
- 149 participants
- Where
- 1 siteJapan
- Study dates
- 6 Dec 2023to 16 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will include adult patients who are diagnosed with hypertrophic cardiomyopathy in Japan, as well as a control group that do not have hypertrophic cardiomyopathy
Who may be able to join
- Participants diagnosed with non-obstructive or obstructive HCM in Japan
- Participants aged ≥18 years of age
- Participants who have been attending outpatient visits for HCM and who are referred to the study by the physician treating HCM
- Participants with HCM who are diagnosed as New York Heart Association (NYHA) functional classification 2-3 at enrolment
- Participants experiencing burden in their daily lives because of HCM (self-reported)
- Participants aged ≥18 years of age
- Individuals from the general population who are enrolled in 3H Clinical Trial's consumer panel
Who cannot join
- Participants who have ever been diagnosed with dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, Fabry disease, or mitochondrial myopathy
- Participants who have previously participated or are currently participating in another clinical trial (not including observational studies)
- Participants who have ever been diagnosed with non-obstructive or obstructive HCM
- Participants who have ever been diagnosed with either dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, Fabry disease, or mitochondrial myopathy
- Participants who have previously participated or are currently participating in another clinical trial (not including observational studies)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases. Phase I is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. Phase II is a quantitative study using questionnaires in participants with hypertrophic cardiomyopathy and a control group of participants who do not have hypertrophic cardiomyopathy.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Quality of life assessment
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life assessmentOther
Quality of life assessment
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with non-obstructive hypertrophic cardiomyopathy | Not described Receives: Other: Quality of life assessment | |
| Participants diagnosed with obstructive hypertrophic cardiomyopathy | Not described Receives: Other: Quality of life assessment | |
| Control group | Not described Receives: Other: Quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant age
Measured: Baseline
Participant sex
Measured: Baseline
Participant height
Measured: Baseline
Participant weight
Measured: Baseline
Participant smoking status
Measured: Baseline
Participant drinking status
Measured: Baseline
Participant employment status
Measured: Baseline
Family members co-residing with participant
Measured: Baseline
Participant comorbidities
Measured: Baseline
Participant mental disorders under current medical treatment
Measured: Baseline
Time from first diagnosis of mental disorders
Measured: Baseline
Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
Measured: Baseline
Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
Measured: Baseline
New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy
Measured: Baseline
History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy
Percutaneous transluminal septal myocardial ablation, pacing therapy, other surgical therapies
Measured: Baseline
Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy
Measured: Baseline
Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM
Measured: Baseline
Patient-reported health-related quality of life assessed by using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire
EQ-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The total score ranges from -0.025 to 1, and higher scores reflect better health status.
Measured: Baseline
Patient-reported health-related quality of life assessed by using the Hospital Anxiety Depression Scale (HADS)
HADS is an anxiety and depression assessment scale consisting of seven items (rated 0, 1, 2, or 3) related to anxiety (subscale A) and seven other items related to depression (subscale D). The total score ranges from 0 to 14, and higher scores reflect a worse health status.
Measured: Baseline
Patient-reported health-related quality of life assessed by using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The KCCQ is a 23-item questionnaire developed to assess HRQoL in patients with congestive heart failure. The KCCQ consists of five domains: physical limitation, symptoms (frequency, severity, and recent change over time), QoL, social interference, and self-efficacy. The total score ranges from 0 to 100, and higher scores reflect better health status.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start6 Dec 2023
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181617
- Sponsor's protocol ID
- CV027-1141
- Status last verified
- Jul 2025
- First submitted
- 13 Dec 2023
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kitaoka H, Kubo T, Torigoe M, Ikeda Y, Shimoura K, Suo S, Takeda R, Maekawa Y. Physical activity and quality of life in patients with hypertrophic cardiomyopathy in Japan: a quantitative study. Future Cardiol. 2026 Oct 13:1-12. doi: 10.1080/14796678.2026.2745404. Online ahead of print.
PubMed 42870498Maekawa Y, Ikeda Y, Torigoe M, Shimoura K, Suo S, Takeda R, Kitaoka H. Qualitative analysis of experiences, burdens, and needs among patients with hypertrophic cardiomyopathy in Japan. Future Cardiol. 2025 Aug;21(10):759-768. doi: 10.1080/14796678.2025.2526279. Epub 2025 Jul 11.
PubMed 40641461
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
- ClinicalTrials.gov ID
- NCT06181617
- Acronym / sponsor ID
- CV027-1141
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases. Phase I is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. Phase II is a quantitative study using questionnaires in participants with hypertrophic cardiomyopathy and a control group of participants who do not have hypertrophic cardiomyopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with non-obstructive hypertrophic cardiomyopathy | – | Other: Quality of life assessment |
| Participants diagnosed with obstructive hypertrophic cardiomyopathy | – | Other: Quality of life assessment |
| Control group | – | Other: Quality of life assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include adult patients who are diagnosed with hypertrophic cardiomyopathy in Japan, as well as a control group that do not have hypertrophic cardiomyopathy
Key inclusion criteria (7 listed)
- Participants diagnosed with non-obstructive or obstructive HCM in Japan
- Participants aged ≥18 years of age
- Participants who have been attending outpatient visits for HCM and who are referred to the study by the physician treating HCM
- Participants with HCM who are diagnosed as New York Heart Association (NYHA) functional classification 2-3 at enrolment
- Participants experiencing burden in their daily lives because of HCM (self-reported)
Key exclusion criteria (5 listed)
- Participants who have ever been diagnosed with dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, Fabry disease, or mitochondrial myopathy
- Participants who have previously participated or are currently participating in another clinical trial (not including observational studies)
- Participants who have ever been diagnosed with non-obstructive or obstructive HCM
- Participants who have ever been diagnosed with either dilated cardiomyopathy or secondary cardiomyopathy, including cardiac amyloidosis, Fabry disease, or mitochondrial myopathy
- Participants who have previously participated or are currently participating in another clinical trial (not including observational studies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life assessmentQuality of life assessment | Other | Control group, Participants diagnosed with non-obstructive hypertrophic cardiomyopathy, Participants diagnosed with obstructive hypertrophic cardiomyopathy |
Primary outcome
Participant age
Time frame: Baseline
Participant sex
Time frame: Baseline
Participant height
Time frame: Baseline
Participant weight
Time frame: Baseline
Participant smoking status
Time frame: Baseline
Participant drinking status
Time frame: Baseline
Participant employment status
Time frame: Baseline
Family members co-residing with participant
Time frame: Baseline
Participant comorbidities
Time frame: Baseline
Participant mental disorders under current medical treatment
Time frame: Baseline
Time from first diagnosis of mental disorders
Time frame: Baseline
Family history of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
Time frame: Baseline
Period from first diagnosis of hypertrophic cardiomyopathy (HCM) in participants with diagnosed HCM
Time frame: Baseline
New York Heart Association functional classification (self-reported) in participants with diagnosed hypertrophic cardiomyopathy
Time frame: Baseline
History of non-drug therapy in participants with diagnosed hypertrophic cardiomyopathy
Time frame: Baseline
Percutaneous transluminal septal myocardial ablation, pacing therapy, other surgical therapies
Participant need for support/caregivers in participants with diagnosed hypertrophic cardiomyopathy
Time frame: Baseline
Participant current medications for hypertrophic cardiomyopathy in participants with diagnosed with HCM
Time frame: Baseline
Patient-reported health-related quality of life assessed by using the European Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire
Time frame: Baseline
EQ-5D-5L consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The total score ranges from -0.025 to 1, and higher scores reflect better health status.
Patient-reported health-related quality of life assessed by using the Hospital Anxiety Depression Scale (HADS)
Time frame: Baseline
HADS is an anxiety and depression assessment scale consisting of seven items (rated 0, 1, 2, or 3) related to anxiety (subscale A) and seven other items related to depression (subscale D). The total score ranges from 0 to 14, and higher scores reflect a worse health status.
Patient-reported health-related quality of life assessed by using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline
The KCCQ is a 23-item questionnaire developed to assess HRQoL in patients with congestive heart failure. The KCCQ consists of five domains: physical limitation, symptoms (frequency, severity, and recent change over time), QoL, social interference, and self-efficacy. The total score ranges from 0 to 100, and higher scores reflect better health status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Derived from this study: PubMed 42870498Kitaoka H, Kubo T, Torigoe M, Ikeda Y, Shimoura K, Suo S, Takeda R, Maekawa Y. Physical activity and quality of life in patients with hypertrophic cardiomyopathy in Japan: a quantitative study. Future Cardiol. 2026 Oct 13:1-12. doi: 10.1080/14796678.2026.2745404. Online ahead of print.
- Derived from this study: PubMed 40641461Maekawa Y, Ikeda Y, Torigoe M, Shimoura K, Suo S, Takeda R, Kitaoka H. Qualitative analysis of experiences, burdens, and needs among patients with hypertrophic cardiomyopathy in Japan. Future Cardiol. 2025 Aug;21(10):759-768. doi: 10.1080/14796678.2025.2526279. Epub 2025 Jul 11.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant age (time frame: Baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06181617, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.